Straumann USA LLC v. Truabutment Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Straumann USA, LLC (Delaware)
  • Defendant: TruAbutment Inc. (California)
  • Plaintiff’s Counsel: EASTMAN MCCARTNEY DALLMANN LLP
• Case Identification: 8:19-cv-00878, C.D. Cal., 05/09/2019
• Venue Allegations: Venue is alleged to be proper as the Defendant is a California corporation with its principal place of business in the district, where it has also allegedly committed acts of infringement.
• Core Dispute: Plaintiff alleges that Defendant’s dental abutments, marketed as compatible with Plaintiff's implant systems, infringe two patents related to a specific mechanical coupling technology for dental implants.
• Technical Context: The technology concerns the high-precision mechanical interface between a dental implant and an abutment, which is critical for the stability, sterility, and long-term success of dental restorations.
• Key Procedural History: The complaint alleges that Defendant, in its regulatory filings with the FDA, identified Plaintiff’s products as "predicate devices" and explicitly noted that its products copy the patented "CrossFit" connection. It also alleges a 2015 trade show encounter where a representative of Defendant was aware of Plaintiff's patents. A cease-and-desist letter was allegedly sent on the same day the complaint was filed.

Case Timeline

Date	Event
2005-06-03	Priority Date for '904 and '002 Patents
2013-04-02	U.S. Patent No. 8,408,904 Issues
2015-03-03	U.S. Patent No. 8,968,002 Issues
2015	Alleged trade show encounter regarding unlicensed compatible parts
Spring 2017	Alleged launch of Accused Products compatible with Straumann's BLT
2019-05-09	Complaint Filing Date & Cease-and-Desist Letter Sent

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,408,904, "Coupling for a Multi-Part Dental Implant System," Issued April 2, 2013

The Invention Explained

• Problem Addressed: The patent background addresses "a frequent problem" in multi-part dental implant systems: achieving the "correct positioning of the abutment or the secondary part within the dental implant," which is critical for stability and sterility (Compl. ¶18; ’904 Patent, col. 1:16-19).
• The Patented Solution: The invention is a coupling system with a multi-sectioned guiding and lock element designed to ensure a precise, stable, and sterile connection. This system combines a conically tapered section for sealing, a non-tapered section with anti-rotational features (e.g., protrusions and grooves), and a cylindrical section for axial guidance (’904 Patent, Abstract). A key feature is an anti-jamming mechanism where the fastening screw cannot engage unless the abutment is fully seated and rotationally aligned with the implant, thereby avoiding "a wedging of the screw" (’904 Patent, col. 4:53-58; Compl. ¶21).
• Technical Importance: The design aimed to improve the ease-of-use and reliability of implant-abutment connections, reducing the risk of improper assembly by clinicians, which could otherwise compromise the restoration (’904 Patent, col. 2:7-16).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 and alleges infringement of one or more claims (Compl. ¶¶46, 53).
• Independent Claim 1 requires, in part:
  • A dental implant system with an implant, an abutment, and a threaded screw.
  • The abutment having a guiding/lock means with a "first conically tapered section" and a "second non-tapered section" with an anti-rotational means (e.g., a protrusion).
  • The implant having a complementary guiding/lock means with a conical section and a second section with an "annular platform" and grooves.
  • A specific geometric and functional relationship wherein threaded engagement of the screw is "not possible" when the abutment's protrusion is in an "intermediate position on the annular platform of the implant."

U.S. Patent No. 8,968,002, "Coupling for a Multi-Part Dental Implant System," Issued March 3, 2015

The Invention Explained

• Problem Addressed: As a continuation of the application leading to the ’904 Patent, the ’002 Patent addresses the same technical challenge of ensuring correct and stable positioning of an abutment within a dental implant (’002 Patent, col. 2:21-33).
• The Patented Solution: The technology is congruent with the ’904 Patent, describing a mechanical interface with complementary anti-rotational structures on the abutment and implant. The system is designed to prevent the fastening screw from engaging if the components are not correctly aligned rotationally, ensuring proper assembly (’002 Patent, Abstract; Claim 1). The complaint identifies this as part of the same "patented CrossFit connection" technology (Compl. ¶¶15, 19).
• Technical Importance: This patent provides continued protection for the design principles intended to enhance the clinical reliability and safety of the implant-abutment connection (’002 Patent, col. 2:7-16).

Key Claims at a Glance

• The complaint asserts at least independent claim 1 and alleges infringement of one or more claims (Compl. ¶¶69, 76).
• Independent Claim 1 requires, in part:
  • A dental implant system with an implant, an abutment, and a threaded screw.
  • Both the abutment and the implant having complementary guiding and lock means, each comprising a "non-tapered section provided with an anti-rotational means."
  • The anti-rotational means on each component comprises "a surface extending radially."
  • A functional limitation wherein "threaded engagement of the threaded screw to the dental implant is not possible" when the abutment's anti-rotational means is in an "intermediate position" on the implant's anti-rotational means.

III. The Accused Instrumentality

Product Identification

• The accused instrumentalities are several lines of dental abutments sold by Defendant TruAbutment, including its "DS" custom abutments, "angulated screw channel" line, "All-on-T" multi-unit abutments, "T:Loc" overdenture abutments, and "Tru Base" and "Cerec® Ti-Base" abutments (Compl. ¶¶24, 25).

Functionality and Market Context

• The complaint alleges these products are marketed as "compatible" replacements for Plaintiff's genuine abutments and are designed to be used with Plaintiff's bone-level implants featuring the patented CrossFit connection (Compl. ¶¶10, 19, 24). A screenshot from Defendant's website shows a compatibility chart for abutments intended for use with Straumann's SC, NC, and RC implant systems, which utilize the CrossFit connection (Compl. ¶25, p. 8). The complaint alleges that Defendant's regulatory filings with the FDA for its products identify Straumann's implants as "predicate devices" and state that they incorporate the same "design, abutment seat, ... [and] connection" (Compl. ¶29).

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits that were not included in the filing; therefore, the infringement theory is summarized below in prose.

The complaint alleges that TruAbutment's Accused Products directly infringe, either literally or under the doctrine of equivalents, at least Claim 1 of both the ’904 and ’002 patents (Compl. ¶¶46, 47, 69, 70). The infringement theory is that Defendant makes, uses, sells, and imports abutments that, when combined with a Straumann bone-level implant and a locking screw as instructed, form the claimed "dental implant system" (Compl. ¶¶46, 69).

The core of the allegation is that the Accused Products are designed to copy and mate with Straumann’s patented CrossFit connection interface (Compl. ¶¶11, 20). This allegation is supported by several pieces of visual evidence. A figure from the complaint combines a photograph of a Straumann CrossFit connection with a corresponding drawing from the ’904 Patent to illustrate the patented anti-rotational features (Compl. ¶20, p. 6). The complaint then alleges the Accused Products replicate this structure. To support this, it provides a table and diagram purportedly from TruAbutment's own regulatory filings, which explicitly names "Straumann® Bone Level Implants" as predicate devices and includes a drawing labeled "Internal Cross Fit®" (Compl. ¶28, p. 9). The complaint asserts these filings confirm that TruAbutment's products copy the patented design, including the specific features recited in the claims such as the anti-rotational and anti-jamming structures (Compl. ¶¶28, 29).

• Identified Points of Contention:
  • Technical Mismatch: A central question will be whether the precise geometry and function of the Accused Products' connection interface literally read on the claim limitations. This will involve a detailed comparison of features like the non-tapered sections, protrusions, and the annular platform.
  • Functional Operation: The "anti-jamming" feature, recited in both asserted claims as the inability to engage the screw in an "intermediate position," may be a key point of dispute. The analysis will likely focus on whether the accused system actually functions in this specific manner, which may require physical testing and expert evidence.

V. Key Claim Terms for Construction

• The Term: "intermediate position" (’904 Patent, Claim 1; ’002 Patent, Claim 1)

  • Context and Importance: This term is central to the claimed "anti-jamming" safety feature. Its definition will determine whether the accused system must create a specific, stable, but incorrect, resting state to infringe. Practitioners may focus on this term because its construction will dictate the evidence needed to prove or disprove infringement of a key functional limitation.
  • Intrinsic Evidence for a Broader Interpretation: The patentee could argue the term covers any rotational orientation where the anti-rotational features are not engaged, but the abutment is resting on the implant, thereby creating a risk of improper fastening. The purpose is to "provide rotational guidance to the abutment upon insertion" (’904 Patent, col. 8:39-41).
  • Intrinsic Evidence for a Narrower Interpretation: The specification illustrates this concept with specific embodiments, such as where "protrusion 24' is rotated until it is brought in registration with one of the grooves 24"" and fully penetrates it" (’904 Patent, col. 6:10-12). A defendant may argue the term is limited to the specific physical state where a protrusion rests directly on top of the "annular platform" as depicted in these embodiments.

• The Term: "annular platform" (’904 Patent, Claim 1)

  • Context and Importance: This term defines the specific structure within the implant that the abutment rests upon in the "intermediate position." Its scope is directly linked to the interpretation of "intermediate position."
  • Intrinsic Evidence for a Broader Interpretation: The claim describes it functionally as being "interposed between grooves" and adapted to "cooperate with the abutment so as to provide rotational guidance" (’904 Patent, col. 8:35-41). This could be argued to encompass any surface area between the grooves that performs this function.
  • Intrinsic Evidence for a Narrower Interpretation: The figures show distinct platforms (e.g., element 5 in Fig. 2A; element 55 in Fig. 5A; element 65 in Fig. 6A). A defendant could argue the term is limited to a discrete, intentionally designed flat surface, not merely the top edge of the implant body between the grooves.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claim is based on allegations that TruAbutment instructs and encourages dentists and dental labs to use the accused abutments with Straumann implants, thereby completing the infringing system, and does so with knowledge of the patents (Compl. ¶¶53-55, 76-78). The contributory infringement claim alleges the accused abutments are a material, non-staple component especially made and adapted for this infringing use with no substantial non-infringing purpose (Compl. ¶¶61-63, 84-86).
• Willful Infringement: Willfulness is alleged based on both pre- and post-suit knowledge. Pre-suit knowledge is alleged based on a 2015 trade show encounter and, more significantly, on Defendant's own FDA regulatory filings that allegedly identify Straumann's products as predicate devices and acknowledge copying the CrossFit connection (Compl. ¶¶28-30). Post-suit willfulness is based on continued infringement after receiving a cease-and-desist letter dated the same day as the complaint filing (Compl. ¶31).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of claim scope and technical operation: Can the term "intermediate position," which defines the patents' anti-jamming safety feature, be construed to read on the actual physical interaction between the accused TruAbutment abutments and Straumann's implants? The case may turn on evidence of whether screw engagement is truly "not possible" when the components are rotationally misaligned.
• A second key question will involve knowledge and intent: The complaint presents allegations, including the Defendant's own regulatory filings referencing the "Internal Cross Fit®" design, that may support an inference of deliberate copying. A central issue for the claims of willful and indirect infringement will be what these documents and other evidence establish about TruAbutment's state of mind regarding Straumann's patents.